肺动脉高压2期和3期试验的临床试验设计。
Clinical trial design in phase 2 and 3 trials for pulmonary hypertension.
作者信息
Nikkho Sylvia, Fernandes Peter, White R James, Deng Chunqin Cq, Farber Harrison W, Corris Paul A
机构信息
Bayer AG, Clinical Development, Berlin, Germany.
Bellerophon Therapeutics, Warren, NJ, USA.
出版信息
Pulm Circ. 2020 Jul 20;10(4):2045894020941491. doi: 10.1177/2045894020941491. eCollection 2020 Oct-Dec.
Abstract
This article on clinical trial design incorporates the broad experience of members of the Pulmonary Vascular Research Institute's (PVRI) Innovative Drug Development Initiative (IDDI) as an open debate platform for academia, the pharmaceutical industry and regulatory experts surrounding the future design of clinical trials in pulmonary hypertension. It is increasingly clear that the design of phase 2 and 3 trials in pulmonary hypertension will have to diversify from the traditional randomised double-blind design, given the anticipated need to trial novel therapeutic approaches in the immediate future. This article reviews a wide range of differing approaches and places these into context within the field of pulmonary hypertension.
摘要
本文关于临床试验设计，纳入了肺血管研究所（PVRI）创新药物开发计划（IDDI）成员的广泛经验，该计划是一个供学术界、制药行业和监管专家围绕未来肺动脉高压临床试验设计展开公开辩论的平台。鉴于预计在不久的将来需要试验新的治疗方法，越来越明显的是，肺动脉高压2期和3期试验的设计将不得不从传统的随机双盲设计中多样化。本文回顾了广泛的不同方法，并将这些方法置于肺动脉高压领域的背景中。
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